RAC-US Exam PDF [2026] Tests Free Updated Today with Correct 100 Questions
RAPS RAC-US Exam Preparation Guide and PDF Download
The Regulatory Affairs Certification (RAC) US is a professional certification exam that is designed for the regulatory affairs professionals in the United States. Regulatory Affairs Certification (RAC) US certification is offered by the Regulatory Affairs Professionals Society (RAPS) and is considered to be one of the most prestigious certifications for regulatory affairs professionals. The RAC-US certification is recognized globally and is highly valued by employers in the pharmaceutical, medical device, and biotechnology industries.
RAPS RAC-US (Regulatory Affairs Certification US) Certification Exam is a professional certification exam that is designed to test the regulatory knowledge and expertise of professionals in the healthcare industry. Regulatory affairs professionals are responsible for ensuring that healthcare products comply with legal and regulatory requirements, and the RAC-US certification exam is one of the most recognized and respected certifications in the field of regulatory affairs.
The RAC-US certification exam is a valuable credential for regulatory affairs professionals working in the United States. It covers a wide range of topics related to US regulations and laws and is recognized as a valuable credential by many companies in the pharmaceutical, medical device, and biotechnology industries.
NEW QUESTION # 27
Which of the following claims would classify an apple as a drug?
- A. "It will satisfy hunger."
- B. "It will whiten teeth."
- C. "It will make you look younger."
- D. "It will prevent colds."
Answer: D
NEW QUESTION # 28
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?
- A. Document and perform audits.
- B. Ask the vendor to take responsibility.
- C. Request an inspection from a regulatory authority.
- D. Request documentation from the sub-contractor.
Answer: A
NEW QUESTION # 29
During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product
Is distributed globally.
Which of the following is the most appropriate action to take FIRST?
- A. Send a "Dear Dr." letter to customers.
- B. Withdraw the affected product from the markets.
- C. Notify the global regulatory authorities.
- D. Assess the potential safety risk.
Answer: C
NEW QUESTION # 30
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Pre-clinical studies
- B. Phase I clinical trials
- C. Phase I and II clinical trials
- D. Phase III clinical trials
Answer: D
NEW QUESTION # 31
At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?
- A. Clinical affairs
- B. Quality improvement
- C. Regulatory agency
- D. Quality assurance
Answer: D
NEW QUESTION # 32
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?
- A. Request a permanent waiver from the new regulation.
- B. Contact the trade association for advice.
- C. Communicate with the relevant internal departments.
- D. Prepare documents for the files.
Answer: C
NEW QUESTION # 33
According to ICH, what is the MAXIMUM amount of time in calendar days that an organization has from the initial receipt of information to report serious and unexpected ADR of a marketed product to regulatory authorities?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
NEW QUESTION # 34
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Export license
- B. Site license
- C. Product license
- D. Import license
Answer: B
NEW QUESTION # 35
Which of the following is NOT required to be included in a marketing application?
- A. Final printed label
- B. Administrative forms
- C. Quality, safety, and efficacy Information
- D. Evidence of fee payment
Answer: D
NEW QUESTION # 36
In which section of the ICH Common Technical Document will the overview of clinical data appear?
- A. Module 3
- B. Module 2
- C. Module 4
- D. Module 1
Answer: B
NEW QUESTION # 37
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
- A. The manufacturer's experience level with the type of IVD medical device is limited.
- B. The device incorporates well-established technology that is already present in the market.
- C. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
- D. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
Answer: A
NEW QUESTION # 38
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?
- A. Train all new employees on regulatory compliance processes and assign a mentor to them.
- B. Document any failure to follow regulatory compliance processes in employee performance reviews.
- C. Develop documented procedures for regulatory compliance processes and train personnel.
- D. Train employees on all regulatory compliance processes using state-of-the-art systems.
Answer: C
NEW QUESTION # 39
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?
- A. Risk analysis
- B. Risk control
- C. Risk management
- D. Risk estimation
Answer: A
NEW QUESTION # 40
Which term does NOT describe the same concept as the others?
- A. Subsequent entry biologics
- B. Follow-on protein products
- C. Biosimilars
- D. Monoclonal antibody
Answer: D
NEW QUESTION # 41
A process is ultimately validated to ensure which of the following?
- A. The process consistently meets the desired Quantity standards
- B. The process meets the regulatory requirements.
- C. The process consistently produces the desired results.
- D. The process meets the quality system requirements.
Answer: C
NEW QUESTION # 42
A global company has obtained a patent in a specific country for a newly marketed product.
What would be the BEST advice In order to protect the patent in other countries?
- A. File patents of interest in target countries.
- B. Use the community patent system.
- C. Use the Madrid system.
- D. File design patents in target countries.
Answer: A
NEW QUESTION # 43
In addition to protection, what parameters MUST be considered when selecting the primary package (or a product?
- A. Compatibility and safety
- B. Safety and efficacy
- C. Volume and material
- D. Efficacy and material
Answer: A
NEW QUESTION # 44
A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?
- A. Scope and level of detail
- B. Revision history
- C. Expiration date
- D. Relevance to regulations
Answer: D
NEW QUESTION # 45
According to ICH, how many stability time points are normally required to establish a two- year shelf life for a product?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: C
NEW QUESTION # 46
A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?
- A. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision.
- B. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.
- C. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan.
- D. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan.
Answer: C
NEW QUESTION # 47
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Individual plasma donation
- B. Product distribution
- C. Plasma pooling
- D. Plasma fractionation
Answer: B
NEW QUESTION # 48
Which of the following is NOT considered a serious adverse event in a cardiovascular clinical trial?
- A. Subject is hospitalized due to complications of the product administration.
- B. Subject's hospitalization is due to an unscheduled hip operation.
- C. Subject's hospitalization is prolonged during the clinical trial.
- D. Subject is hospitalized for the purpose of product administration.
Answer: D
NEW QUESTION # 49
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